Albuterol Versus Xopenex in Treatment of Acute Asthma in the Emergency Department (ED) (NCT00585039) | Clinical Trial Compass
CompletedPhase 4
Albuterol Versus Xopenex in Treatment of Acute Asthma in the Emergency Department (ED)
United States101 participantsStarted 2005-09
Plain-language summary
The purpose of this study is to determine in a large, double-blind, randomized, prospective pediatric clinical trial whether the use of continuous levalbuterol (Xopenex) in addition to standard emergency department treatment for acute asthma exacerbations will improve the Forced Expiratory Volume in 1 sec (FEV 1) compared to the use of continuous racemic albuterol. The secondary objective is to correlate clinical (hospitalization rates and clinical asthma scores) with plasma levels of (S)-albuterol.
Who can participate
Age range
6 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient is between the ages of 6 and 17
* Has previously been diagnosed with asthma by any physician
* Has presented to the ED with an asthma exacerbation judged by a physician to be of a moderate or severe degree
Exclusion Criteria:
* Requires immediate resuscitation (attending physician)
* Is pregnant and/or breast feeding
* If possibly pregnant, negative pregnancy test attached
* Has chronic lung diseases (i.e. cystic fibrosis)
* Has an uncorrected congenital heart diseaseHas a suspected foreign body aspiration
* Is allergic to albuterol and/or levalbuterol (Xopenex)
* Has an initial FEV 1\>70% predicted
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Forced Expiratory Volume in 1 Sec (FEV1) Measured in L/Sec